BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 14986648 · Received July 12, 2022

    Report

    Report Number
    1221359-2022-03312
    Event Type
    Malfunction
    Date Received
    July 12, 2022
    Date of Event
    May 29, 2022
    Report Date
    July 14, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. PLEASE REFERENCE ALL RELATED MFR. REPORT NUMBERS: 1221359-2022-03311 THROUGH 1221359-2022-03318. .

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION TO THE PREVIOUSLY REPORTED EVENT. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1063783 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER 190-000 / LOT 1063783 AND TEST BASE PART NUMBER 190-430 / LOT 1063783. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS CONFLICTING RESULT PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1063783 SHOWED THAT THE COMPLAINT RATE IS (B)(4)% IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE AN ASSIGNABLE ROOT CAUSE, AS THE LOG FILES WERE NOT PROVIDED FOR INVESTIGATION. .

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED EIGHT (8) FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED BETWEEN (B)(6) 2022 AND (B)(6) 2022, USING FOUR DIFFERENT LOT NUMBERS (1063783, 1063392, 1056062 AND 1071468). THIS MFR. REPORT IS TWO( 2) OF EIGHT (8) RESULT, AND ADDRESS LOT 1063783 (TOTAL QUANTITY 5) THE CUSTOMER REPORTED ONE FALSE NEGATIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2022 WITH THE KIT SWAB ON A NASAL SWAB SAMPLE. CONFIRMATION TESTING (PCR PLATFORM: CORE LAB) ON A NASOPHARYNGEAL SAMPLE COLLECTED ON (B)(6) 2022 IN VIRAL TRANSPORT MEDIA GENERATED A POSITIVE RESULT (CT VALUES NOT PROVIDED). NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1638634 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1063783 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown